《BS-EN-60645-1-2001 IEC-60645-1-2001.pdf》由会员分享，可在线阅读，更多相关《BS-EN-60645-1-2001 IEC-60645-1-2001.pdf（40页珍藏版）》请在三一文库上搜索。
1、BRITISH STANDARD BS EN 60645-1:2001 IEC 60645-1:2001 Electroacoustics Audiological equipment Part 1: Pure-tone audiometers The European Standard EN 60645-1:2001 has the status of a British Standard ICS 17.140.50 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Licensed Copy: sh
2、effieldun sheffieldun, na, Thu Nov 09 01:22:01 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 60645-1:2001 This British Standard, having been prepared under the direction of the Electrotechnical Sector Policy and Strategy Committee, was published under the authority of the Standards Policy and Str
3、ategy Committee on 19 November 2001 BSI 19 November 2001 ISBN 0 580 38676 7 National foreword This British Standard is the official English language version of EN 60645-1:2001. It is identical with IEC 60645-1:2001. It supersedes BS EN 60645-1:1995 which is withdrawn. The UK participation in its pre
4、paration was entrusted to Technical Committee EPL/29, Eletroacoustics, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. From 1 January 1997, all IEC publications have the number 60000 added to the old number. For inst
5、ance, IEC 27-1 has been renumbered as IEC 60027-1. For a period of time during the change over from one numbering system to the other, publications may contain identifiers from both systems. Cross-references The British Standards which implement international or European publications referred to in
6、this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. U
7、sers of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible European committee any enquiries on the interpretation, or proposals
8、 for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 37, and a back cover. The BSI copyright date displayed
9、in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 09 01:22:01 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARDEN 60645-1 NORME EUROPENNE EUROPISCHE NORMOctober 2001 C
10、ENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B - 1050 Brussels 2001 CENELEC -All rights of exploitation in any form and by any means reserved wo
11、rldwide for CENELEC members. Ref. No. EN 60645-1:2001 E ICS 17.140.50Supersedes EN 60645-1:1994 English version Electroacoustics - Audiological equipment Part 1: Pure-tone audiometers (IEC 60645-1:2001) Electroacoustique - Appareils daudiologie Partie 1: Audiomtres tonaux (CEI 60645-1:2001) Akustik
12、- Audiometer Teil 1: Reinton-Audiometer (IEC 60645-1:2001) This European Standard was approved by CENELEC on 2001-09-25. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard wi
13、thout any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CENELEC member. This European Standard exists in three official versions (English, French, German). A version in any other lang
14、uage made by translation under the responsibility of a CENELEC member into its own language and notified to the Central Secretariat has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Czech Republic, Denmark, Finland, France
15、, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 09 01:22:01 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 64605-:10021- 2 - Foreword The text of document 2
16、9/489/FDIS, future edition 2 of IEC 60645-1, prepared by IEC TC 29, Electroacoustics, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60645-1 on 2001-09-25. This European Standard supersedes EN 60645-1:1994. The following dates were fixed: latest date by which the EN
17、 has to be implemented at national level by publication of an identical national standard or by endorsement(dop)2002-07-01 latest date by which the national standards conflicting with the EN have to be withdrawn(dow)2004-10-01 Annexes designated “normative“ are part of the body of the standard. Anne
18、xes designated “informative“ are given for information only. In this standard, annex ZA is normative. Annex ZA has been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 60645-1:2001 was approved by CENELEC as a European Standard without any modification. In the offic
19、ial version, for Bibliography, the following note has to be added for the standard indicated: IEC 61260NOTEHarmonized as EN 61260:1995 (not modified). _ Page 2 EN 606451:2001 BSI 19 November 2001 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 09 01:22:01 GMT+00:00 2006, Uncontrolled Copy, (c) B
20、SI 066-541 ? EI:C0021 3 CONTENTS INTRODUCTION 6 1Scope and object. 7 2Normative references. 7 3Terms and definitions 9 4Requirements for specific types of fixed frequency audiometer .12 5General requirements .13 5.1Electrical safety requirements13 5.2Acoustic safety requirements.14 5.3Environmental
21、conditions.14 5.4Warm-up time14 5.5Power supply variation.14 5.5.1Mains operation .14 5.5.2Battery operation .14 5.6Immunity to power and radio frequency fields 14 5.7Unwanted sound15 5.7.1General15 5.7.2Unwanted sound from an earphone15 5.7.3Unwanted sound from a bone vibrator15 5.7.4Unwanted sound
22、 radiated by an audiometer.15 5.8Testing of automatic recording and computer-controlled audiometers 15 5.9Interface connections.16 6Test signal sources.16 6.1Pure tones.16 6.1.1Frequency range and hearing level range 16 6.1.2Frequency accuracy.16 6.1.3Total harmonic distortion17 6.1.4Rate of frequen
23、cy change 17 6.2Frequency modulation .18 6.3External signal source .18 6.3.1Signals 18 6.3.2Frequency response 18 6.3.3Electrical sensitivity .19 6.3.4Reference level for external signal source. 19 6.3.5Operator to subject speech communication19 6.3.6Subject to operator speech communication19 6.4Mas
24、king sound 19 6.4.1General19 6.4.2Narrow-band noise.19 6.4.3Other masking sound.20 Page 3 EN 606451:2001 BSI 19 November 2001 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 09 01:22:01 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 066-541 ? EI:C0021 4 7Loudspeaker output 21 8Signal level control .
25、21 8.1Marking .21 8.2Signal indicator21 8.3Accuracy of sound pressure level and vibratory force level 22 8.4Hearing level control22 8.4.1Manual audiometers.22 8.4.2Automatic-recording audiometers.22 8.4.3Computer-controlled audiometers 22 8.4.4Accuracy of control 23 8.5Masking level control.23 8.5.1
26、General23 8.5.2Masking level.23 8.5.3Accuracy of masking levels23 8.5.4Masking level range.23 8.6Tone switching 24 8.6.1Tone switch for manual audiometers24 8.6.2On/off ratio for manual audiometers.24 8.6.3Rise/fall times for manual audiometers 24 8.6.4Automatic pulsed presentation.24 8.6.5Subjects
27、response time with computer-controlled audiometers25 8.6.6Subjects response system 25 9Reference tone .26 9.1General .26 9.2Frequencies.26 9.3Reference tone level control 26 9.3.1Range26 9.3.2Intervals.26 9.3.3Marking26 9.3.4Accuracy26 9.3.5Operation.26 10Calibration 27 10.1 General .27 10.2 Supra-a
28、ural earphone headband27 10.3 Bone vibrator headband.27 11Electrical output27 12Audiogram format .28 13Demonstration of conformity with specifications and test procedures 28 13.1 General .28 13.2 Environmental conditions and power supply variation 28 13.3 Immunity to power and radio frequency fields
29、 29 Page 4 EN 606451:2001 BSI 19 November 2001 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 09 01:22:01 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 066-541 ? EI:C0021 5 13.4 Unwanted sound29 13.4.1 Earphone.29 13.4.2 Unwanted sound from a bone vibrator30 13.4.3 Unwanted sound radiated by an au
30、diometer.30 13.5 Test signal sources30 13.6 Signal accuracy .31 13.6.1 Accuracy of sound pressure level and vibratory force.31 13.6.2 Accuracy of control 31 13.7 Masking sound 31 13.7.1 Narrow-band noise.31 13.7.2 Masking level.31 13.8 Headbands 31 13.8.1 Supra-aural earphone headband31 13.8.2 Bone
31、vibrator headband.32 14Maximum permitted expanded uncertainty of measurements.32 15Marking and instruction manual 32 15.1 Marking .32 15.2 Instruction manual .33 Bibliography34 Annex ZA (normative) Normative references to international publications with their corresponding European publications .35
32、Figure 1 Rise/fall envelope of test tones.25 Table 1 Minimum facilities for fixed-frequency audiometers13 Table 2 Minimum number of frequencies to be provided and the minimum range of values of hearing level for fixed frequency audiometers 17 Table 3 Maximum permissible acoustic total harmonic disto
33、rtion, expressed in percentage of sound pressure or vibratory force for supra-aural, circumaural, insert earphones and bone vibrators .17 Table 4 Narrow-band masking noise: Upper and lower cut-off frequencies for a sound pressure spectrum density level of 3 dB referred to the level at the centre fre
34、quency of the band20 Table 5 Reference standards for obtaining audiometric zero 27 Table 6 Symbols for the graphical presentation of hearing threshold levels 28 Table 7 Values of Umax for basic measurements .32 Page 5 EN 606451:2001 BSI 19 November 2001 Licensed Copy: sheffieldun sheffieldun, na, Th
35、u Nov 09 01:22:01 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 066-541 ? EI:C0021 6 INTRODUCTION Developments in the field of hearing measurements for diagnostic, hearing conservation and rehabilitation purposes have resulted in the availability of a wide range of audiometers. In addition it is possib
36、le to consider the audiometer in terms of a set of functional units which can be specified independently. By specifying these functional units it is then possible to specify the performance of other audiometric equipment which uses these units. IEC 60645 consists of a number of parts. IEC 60645-1 is
37、 the first in the series and covers the requirements for pure tone audiometers. Due to the development of the later parts of IEC 60645, part 1 now confines its scope solely to the requirements of pure tone audiometers. One consequence of this is that no reference is now made to the use of broad-band
38、 noise for masking. Requirements for broad-band masking noise now only relate to its use with speech signals as described in IEC 60645-2. This second edition now specifies performance requirements separate from the test requirements to show conformity. Conformance to the specifications in this Inter
39、national Standard is demonstrated only when the result of a measurement, extended by the actual expanded uncertainty of measurement of the testing laboratory, lies fully within the tolerances specified in this International Standard extended by the values for Umax given in table 7. By this, the tole
40、rances that are to be met by the manufacturer of an audiometer are essentially the same as in the first edition of IEC 60645-1, while the tolerances as applicable to the use of the audiometer are increased by Umax compared with those of the previous edition. Page 6 EN 606451:2001 BSI 19 November 200
41、1 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 09 01:22:01 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 066-541 ? EI:C0021 7 ELECTROACOUSTICS AUDIOLOGICAL EQUIPMENT Part 1: Pure-tone audiometers 1 Scope and object This part of IEC 60645 specifies general requirements for audiometers and particu
42、lar requirements for pure-tone audiometers designed for use in determining hearing threshold levels, in comparison with standard reference threshold levels by means of psychoacoustic test methods. The object of this International Standard is to ensure: a) that tests of hearing, particularly threshol
43、d, in the frequency range 125 Hz to 8 000 Hz on a given human ear performed with different audiometers which comply with this International Standard using methods described in ISO 8253-1 and ISO 6189 shall give substantially the same results; b) that the results obtained represent a valid comparison
44、 between the hearing of the ear tested and the reference threshold of hearing; c)that audiometers are classified according to the range of test signals they generate, according to the mode of operation or according to the complexity of the range of auditory functions they test. 2 Normative reference
45、s The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of IEC 60645. For dated references, subsequent amend- ments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this part
46、of IEC 60645 are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid Internati
47、onal Standards. IEC 60126, IEC reference coupler for the measurement of hearing aids using earphones coupled to the ear by means of ear inserts IEC 60268-3, Sound system equipment Part 3: Amplifiers IEC 60318-1, Electroacoustics Simulators of human head and ear Part 1: Ear simulator for the calibrat
48、ion of supra-aural earphones IEC 60318-2, Electroacoustics Simulators of human head and ear Part 2: An interim acoustic coupler for the calibration of audiometric earphones in the extended high frequency range IEC 60318-3, Electroacoustics Simulators of human head and ear Part 3: Acoustic coupler fo
49、r the calibration of supra-aural earphones used in audiometry IEC 60373, Mechanical coupler for measurements on bone vibrators IEC 60601-1, Medical electrical equipment Part 1: General requirements for safety Page 7 EN 606451:2001 BSI 19 November 2001 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 09 01:22:01 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 066-541 ? EI:C0021 8 IEC 60601-1-2, Medical electrical equipment Part 1-2: General requirements for safety Collateral Stand